Patient leaflet - Ibuprofen 200 mg film-coated tablets
1. What Ibuprofen is and what it is used for
The active ingredient (which makes the medicine work) is Ibuprofen. Ibuprofen tablets belongs to a group of medicines called anti-inflammatory pain killers. They can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), arthritis of the spine, ankylosing spondylitis, swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains. Ibuprofen Tablets can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.
The active ingredient in Ibuprofen Tablets is ibuprofen and each tablet contains 200 mg.
2. What you need to know before you take Ibuprofen
Do not take this medicine if you:
- If you are pregnant or planning to become pregnant, or are you breast-feeding? Ibuprofen tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
- If you have a condition which increases your tendency to bleeding?
- If you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers?
- are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other painkillers
- if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past''
- have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines
- Do not take Ibuprofen Tablets if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.
- are taking other NSAIDs (Non-Steroidal Anti-inflammatory Drugs)
- are taking more than 75 mg of aspirin a day. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take this medicine
- have severe liver or kidney problems
- have heart problems, high blood pressure or blood coagulation disorder
- have breathing difficulties
- are in the last 3 months of pregnancy
- are under 12 years old.
Check with your pharmacist or your doctor before taking this product if you:
- have chicken pox or shingles
- Have you been told by your doctor that you have an intolerance to some sugars.
- have or have had asthma
- have kidney, heart, liver or bowel problems
- have high cholesterol or previously have had a heart attack or stroke
- have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)
- have Systemic Lupus Erythematosus (SLE, sometimes known as lupus - a condition of the immune system causing joint pain skin changes and other organ disorders) or a connective tissue disease (autoimmune diseases affecting connective tissue)
- are a smoker
- are in the first 6 months of pregnancy.
- have an infection. This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using ibuprofen Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately ibuprofen Tablets and contact immediately your doctor or medical emergencies if you notice any of these signs.
Taking other medicines
To reduce the risk of side effects, do not take this product with other NSAID containing products (e.g. aspirin, ibuprofen…). If you are on low-dose aspirin (up to 75 mg daily), speak to your doctor or pharmacist before you take this medicine.
This medicine may affect or be affected by some other medicines. For example:
Avoid taking this product with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed:
medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
- to stimulate your heart cardiac glycosides, such as digoxin, used to treat heart conditions
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
- to help you passing water (diuretics)
- medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response)
- for mania or depression (e.g. Lithium or SSRIs)
- for pregnancy termination (e.g. mifepristone)
- for HIV treatment (e.g. zidovudine)
- any other ibuprofen, such as those you can buy without a prescription
- any other anti-inflammatory pain killer, including aspirin
- cholestyramine (a drug used to lower cholesterol)
- medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
- voriconazole or fluconazole (type of anti-fungal drugs)
- gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
- antibiotics called quinolones such as ciprofloxacin
- aminoglycosides (a type of antibiotic)
- steroids (used in the treatment of inflammatory conditions)
- methotrexate (used to treat certain cancers and rheumatoid arthritis)
Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.
Other warnings
- This medicine belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
- Anti-inflammatory/pain-killer medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
- You should discuss your treatment with your doctor or pharmacist before taking this medicine if you: - have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack 'TIA'). - have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
- Are you or your child dehydrated?There is a risk of renal impairment/kidney damage in dehydrated children and adolescents and the elderly.
- If you are taking this medicine for longer than the recommended time or at higher than recommended doses you are at risk of serious harm. These include serious harm to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).
Alcohol: Ibuprofen may cause some side effects including dizziness, drowsiness and stomach problems such as bleeding in the stomach. Drinking excessive alcohol with ibuprofen might make these side effects worse.
Driving and Using Machines:
Ibuprofen may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.'
Pregnancy and breast feeding
The use of Ibuprofen whilst pregnant or breast feeding should be avoided.
Do not take ibuprofen if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn
baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, ibuprofen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Female fertility
Ibuprofen belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take ibuprofen occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take ibuprofen
ALWAYS take Ibuprofen exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.
Take your Ibuprofen Tablets with or after food, with a glass of water. Ibuprofen Tablets should be swallowed whole and not chewed, broken, crushed or sucked to help prevent discomfort in the mouth or irritation in the throat.
This product is for short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
DOSAGE:
Adults and children over 12 years - The usual dosage is 600 to 1800 mg spread throughout the day. Your doctor may choose to increase this depending on what you are being treated for; but no more than 2400 mg should be taken in one day.
Children – The usual daily dose is 20 mg per kg of bodyweight each day, given in divided doses.
Ibuprofen tablets should NOT be taken by children weighing less than 7 kg.
In cases of severe juvenile arthritis your doctor my increase the dosage up to 40 mg/kg in divided doses.
You should avoid excessive use of painkillers. If you usually take painkillers, especially combinations of different painkillers, you may
damage your kidneys, tell your doctor if you are already taking another painkiller before taking this medicine and your doctor will decide whether you should take this medicine. This risk may be increased if you are dehydrated.
The use of painkillers for a long period of time has in some patients been linked to headaches, a condition called medication overuse headache (MOH). Patients who have frequent or daily headaches despite (or because of) the regular use of pain killers should not be treated with increased doses of Ibuprofen.
Tell your doctor if you have been having headaches while taking this medicine. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
If you forgot to take this medicine.
Take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.
4. Possible side effects
As with all medicines, Ibuprofen Tablets may cause side effects, although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.
The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, heamatemesis, ulcerative stomatits, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infraction) or stroke. Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs.
STOP TAKING Ibuprofen Tablets and seek immediate medical help if you experience:
Liver, kidney problems or difficulty urinating
Ibuprofen, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness
- Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck or intolerance to bright light.
- Signs of intestinal bleeding such as
- Passing blood in your faeces (stools/motions)
- Passing black tarry stools
- Vomiting any blood or dark particles that look like coffee grounds
- Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens- Johnson syndrome, toxic epidermal necrolysis].
- Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
- A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever.
The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
TELL YOUR DOCTOR AND STOP TAKING IBUPROFEN TABLETS IF YOU EXPERIENCE:
- Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.
- Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms of an allergic reaction).
- Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
Medicines such as Ibuprofen Tablets have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure.
Medicines such as Ibuprofen Tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles.
Blood disorders such as reduction in blood cells and platelet counts
- the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with ibuprofen.
Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.
Other possible side effects with Ibuprofen are:
Very common: may affect more than 1 in 10 people
- Indigestion or heartburn
- Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
Common (affects up to 1 in 10 people):
- feeling dizzy or tired
- diarrhoea, wind, constipation
headache - if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.
Uncommon (affects up to 1 in a 100 people):
- feeling drowsy
- feeling anxious
- feeling a tingling sensation or ‘pins and needles’
- difficulty sleeping
- hives
- skin becomes sensitive to light
- hearing problems
- sneezing, blocked, itchy or runny nose (rhinitis)
- stomach or gut ulcer, hole in the wall of the digestive tract
- inflammation of your stomach lining
- ringing in ears (tinnitus)
- sensation of spinning (vertigo)
- mouth ulcers
- visual disturbances
- hypersensitivity reactions such as hives, itching, purpura, exanthema, asthma attacks (sometimes with low blood pressure)
- photosensitivity (increased sensitivity to sunlight)
Rare (affects up to 1 in a 1000 people):
- feeling depressed or confused
- vision loss
Very rare (affects up to 1 in 10,000 people):
- Inflammation of the oesophagus or pancreas sudden filling of lungs with water resulting in difficulty to breathe high blood pressure water retention and weight gain
Not known (cannot be estimated from the available data):
- Skin reactions that often occur at the same body site after repeated intake of the drug.
- Tingling of the hands and feet
- Anxiety
- Impaired hearing
- General feeling of being unwell
- Inflammation of the optic nerve which may cause vision problems
- A severe skin reaction known as DRESS syndrome can occur.
Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
- A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen tablets if you develop these symptoms and seek medical attention immediately. See also section 2.
Ibuprofen may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ibuprofen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original pack.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ibuprofen contains
The active substances is Ibuprofen.
Each film-coated tablet contains 200 mg ibuprofen.
The other ingredients are:
Maize Starch B, Sodium lauryl sulfate, Colloidal silicon dioxide, Croscarmellose sodium, Povidone, Microcrystalline Cellulose, Talc, Stearic acid, Opadry White (macrogol (peg) polyvinyl alcohol graft copolymer, talc, titanium dioxide, gmcc type 1 /mono/diglycerides/ glycerol of FA, polyvinyl alcohol-part. hydrolyzed)
What Ibuprofen looks like and contents of the pack
Film-coated tablet.
Ibuprofen 200 mg film-coated tablets White coloured, capsule shaped coated tablets plain on one side and debossed “200” on other side.
Pack sizes:
Blisters: 200 mg: film-coated tablets: 16 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
RxFarma Limited, Colonial Way, Watford, Hertfordshire, WD24 4YR, United Kingdom.
Manufacturer:
Rx Farma Limited, Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR, UK.